HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Summary
The FDA issued a Class II for HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) by LIEBEL-FLARSHEIM COMPANY LLC. Reason: Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall no.
Details
Source
Device Recall
External ID
Z-1992-2021
Action Date
2021-07-14
Status
Terminated
Category
device
Product Description
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Lot/Code Info: Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
Quantity Affected: 17
Reason for Recall
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Distribution
US Nationwide Distribution and in the country of Canada
Type: FDA Mandated
Recall Initiated: 2021-03-11
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LIEBEL-FLARSHEIM COMPANY LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LIEBEL-FLARSHEIM COMPANY LLC have FDA actions?
This is the only FDA action we have on record for LIEBEL-FLARSHEIM COMPANY LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1992-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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